NCT06734156 CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
| NCT ID | NCT06734156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gulbenkian Institute for Molecular Medicine |
| Condition | Colorectal Cancer (CRC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2026-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2026-03-02 with a primary completion date of 2026-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths globally, with increasing incidence rates. While predominantly affecting older adults, CRC cases among individuals under 50 (early-onset CRC, or EoCRC) are rising. This age group rarely undergoes routine screening, resulting in delayed diagnoses and more advanced disease at presentation. In the USA, EoCRC accounts for 10% of CRC cases and is the leading cause of cancer-related deaths in men under 50. Despite the increase in EoCRC incidence, the causes remain unclear. Only 25% of cases have a CRC family history, suggesting environmental factors. Diets low in fibre and rich in fat and red meat, obesity, alcohol consumption, sedentary lifestyle, stress, and chronic inflammation of the GI tract are estimated to account for 70-90% of CRC risk. According to the World Cancer Research Fund, 47% of all CRC cases could be prevented through lifestyle changes, particularly in diet and physical activity. These lifestyle factors are also strongly linked to changes in the gut microbiome, which differs markedly between CRC patients and healthy individuals. The microbiome may influence tumour development by producing metabolites that regulate immune responses or create anti-tumour environments. Thus, the gut microbiome is a promising target for early CRC detection and prevention. This study aims to develop a non-invasive, microbiome-based diagnostic tool for CRC, identifying biomarkers to improve early detection, personalise treatment, and reduce healthcare costs.
Eligibility Criteria
Inclusion Criteria: * Be willing and able to provide written informed consent * Resident in Portugal * Age from 40 to 74 years * Have a recent diagnosis of CRC without initiating any treatment. Exclusion Criteria: * Age \< 40 years or ≥ 75 years * Unable to provide informed consent * Refusal to provide stool samples * Previous or current treatment for CRC * First-degree family history of CRC * Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, recurrent infection by Clostridioides difficile * Pregnancy
Contact & Investigator
Ana S Almeida, PhD
PRINCIPAL INVESTIGATOR
Gulbenkian Institute for Molecular Medicine
Frequently Asked Questions
Who can join the NCT06734156 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 74 Years, studying Colorectal Cancer (CRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06734156 currently recruiting?
Yes, NCT06734156 is actively recruiting participants. Contact the research team at ana.almeida@gimm.pt for enrollment information.
Where is the NCT06734156 trial being conducted?
This trial is being conducted at Lisbon, Portugal, Lisbon, Portugal.
Who is sponsoring the NCT06734156 clinical trial?
NCT06734156 is sponsored by Gulbenkian Institute for Molecular Medicine. The principal investigator is Ana S Almeida, PhD at Gulbenkian Institute for Molecular Medicine. The trial plans to enroll 400 participants.
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